Exoskeleton device

ABSTRACT

A method of using an ankle exoskeleton device is provided herein. The method includes collecting one or more biomechanical data points from an individual. The method also includes developing individualized musculoskeletal simulations based on the one or more biomechanical data points. In addition, the method includes creating predictive simulations by modeling effects of an ankle exoskeleton device on the individualized musculoskeletal simulations. The method also includes utilizing established device-user relationships with real-time measurements to adjust device control. Lastly, the method includes optimizing design and control parameters of the exoskeleton device based on the predictive simulations and user responses.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application No.62/670,465 filed on May 11, 2018, the entire contents of which isincorporated herein by reference.

FIELD OF THE INVENTION

The present disclosure generally relates to the field of rehabilitationrobotics.

Specifically, the disclosure describes methods, implementations, anddevices related to exoskeleton device gait rehabilitation.

BACKGROUND OF THE INVENTION

A number of injuries or conditions can lead to disorders that affectmuscle control.

Individuals with muscle control disorders frequently experience adownward trend of reduced physical activity and worsening of gaitfunction leading to a permanent decline in ambulatory ability.Accordingly, it is desired to develop methods, implementations, anddevices for gait rehabilitation.

SUMMARY OF THE INVENTION

According to some aspects of the present disclosure, a method of usingan ankle exoskeleton device is disclosed. The method includes collectingone or more biomechanical data points from an individual. The methodalso includes developing individualized musculoskeletal simulationsbased on the one or more biomechanical data points. The method furtherincludes creating predictive simulations by modeling effects of an ankleexoskeleton device on the individualized musculoskeletal simulations.Lastly, the method includes optimizing design and control parameters ofthe ankle an exoskeleton device based on the predictive simulations.

In a further non-limiting embodiment of any of the foregoing and/orensuing methods of using an ankle exoskeleton device, the method alsoincludes determining an individual gait deficit of the individual bycomparing the individualized musculoskeletal simulations to a simulationof a healthy individual.

In a further non-limiting embodiment of any of the foregoing and/orensuing methods of using an ankle exoskeleton device, the designparameters include a control algorithm that utilizes data point from anembedded sensor on the exoskeleton device to track at least one datapoint, evaluates how the at least one data point changes over time, andadjusts a level of assistance provided by the exoskeleton device.

In a further non-limiting embodiment of any of the foregoing and/orensuing methods of using an ankle exoskeleton device, the developing ofindividualized musculoskeletal simulations based on the one or morebiomechanical data points utilizes wearable sensors or sensors embeddedwithin the exoskeleton device.

In a further non-limiting embodiment of any of the foregoing and/orensuing methods of using an ankle exoskeleton device, the developingindividualized musculoskeletal simulations based on the one or morebiomechanical data points includes determining an individual's gaitdeficits by comparing the results of the individualized musculoskeletalsimulations to the data point collected on other individuals using theexoskeleton device.

In a further non-limiting embodiment of any of the foregoing and/orensuing methods of using an ankle exoskeleton device, the method furtherincludes collecting one or more biomechanical data points from anindividual.

In a further non-limiting embodiment of any of the foregoing and/orensuing methods of using an ankle exoskeleton device, optimizing designparameters of the exoskeleton device based on the predictive simulationsfurther comprises augmenting existing muscle activity to elicitfunctional changes of the individual through activation of one or moreactuators.

In a further non-limiting embodiment of any of the foregoing and/orensuing methods of using an ankle exoskeleton device, the method furtherincludes assisting the individual during a gait cycle throughmanipulation of the exoskeleton device.

In a further non-limiting embodiment of any of the foregoing and/orensuing methods of using an ankle exoskeleton device, the method furtherincludes resisting the individual during a gait cycle throughmanipulation of the exoskeleton device.

According to some aspects of the present disclosure, a wearableassistance system is provided herein that includes an ankle exoskeletondevice comprising a control unit including a controller and a motor inelectrical communication with the controller. The wearable assistancesystem also includes a measurement device configured to generatebiomechanical data point of an individual. The measurement device isconfigured to determine an individual's gait deficits and the controlleris configured to actuate the motor at an initial level of assistancebased on the gait deficits.

In a further non-limiting embodiment of any of the foregoing and/orensuing exoskeleton devices, the generated biomechanical data point ofthe individual is compared to a computer-generated model of a gaitcycle.

In a further non-limiting embodiment of any of the foregoing and/orensuing exoskeleton devices, the measurement device is a motion capturecamera configured to detect movement and force gait analysis.

In a further non-limiting embodiment of any of the foregoing and/orensuing exoskeleton devices, the measurement device utilizes ameasurement of muscle activity through electromyography.

In a further non-limiting embodiment of any of the foregoing and/orensuing exoskeleton devices, the measurement device utilizes ameasurement of oxygen consumption/CO2 production to determine ametabolic rate.

In a further non-limiting embodiment of any of the foregoing and/orensuing exoskeleton devices, the actuator is operably coupled to ahinged assembly through a transmission assembly and configured toactuate the hinged assembly when the actuator is activated by thecontroller.

In a further non-limiting embodiment of any of the foregoing and/orensuing exoskeleton devices, the hinged assembly includes an insolebracket rotatably coupled with an upright member.

According to some aspects of the present disclosure, a method of usingan exoskeleton device is provided herein that includes collecting one ormore biomechanical data points from an individual. The method alsoincludes developing individualized musculoskeletal simulations based onthe one or more biomechanical data points. The method further includescreating predictive simulations by modeling effects of an ankleexoskeleton device on the individualized musculoskeletal simulations. Inaddition, the method includes utilizing established biomechanicalrelationships governing the interaction between the device and theindividual. Lastly, the method includes optimizing design or controlparameters of the exoskeleton device based on the predictivesimulations.

In a further non-limiting embodiment of any of the foregoing and/orensuing methods of using an ankle exoskeleton device, the collecting oneor more biomechanical data points from an individual includes utilizingmotion capture of movement and force gait analysis via motion capturecameras utilizing on-board device sensors.

In a further non-limiting embodiment of any of the foregoing and/orensuing methods of using an ankle exoskeleton device, the collecting oneor more biomechanical data points from an individual includes utilizinga measurement of muscle activity through electromyography.

In a further non-limiting embodiment of any of the foregoing and/orensuing methods of using an ankle exoskeleton device, the collecting oneor more biomechanical data points from an individual includes utilizinga measurement of oxygen consumption/CO2 production to determine ametabolic rate.

These and other aspects, objects, and features of the present inventionwill be understood and appreciated by those skilled in the art uponstudying the following specification, claims, and appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a flowchart of a natural progression of ambulatory decline inindividuals with various gait disorders;

FIG. 2 is a graph of the differences in daily total step count byvarious persons having cerebral palsy (CP) at various functional levels;

FIG. 3 is a front isometric view of a wearable exoskeleton device;according to some embodiments;

FIG. 4 is a front isometric view of a control unit of the exoskeletondevice of FIG. 3, according to some embodiments;

FIG. 5 is a rear isometric view of the exoskeleton device of FIG. 3,according to some embodiments;

FIG. 6 is a side plan view of a lower hinged assembly that is operablycoupled with the control unit through a transmission assembly, accordingto some embodiments;

FIG. 7 is a block diagram of the exoskeleton device, according to someembodiments;

FIG. 8 is a diagram illustrating a knee joint angle that may be measuredthrough the usage of the exoskeleton device, according to someembodiments;

FIG. 9 is a block diagram of the exoskeleton device communicativelycoupled with various other devices through a network/cloud, according tosome embodiments;

FIG. 10 is a flowchart of a method of optimizing design parameters ofthe exoskeleton device, according to various embodiments; and

FIG. 11 is a flowchart of a method of dynamically (intermittently)updating a level of assistance provided by the exoskeleton device basedon a sensor data point, according to some embodiments.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

For purposes of description herein, the terms “upper,” “lower,” “right,”“left,” “rear,” “front,” “vertical,” “horizontal,” and derivativesthereof shall relate to the embodiment of the invention as oriented inFIG. 3. However, it is to be understood that the invention may assumevarious alternative orientations, except where expressly specified tothe contrary. It is also to be understood that the specific devices andprocesses illustrated in the attached drawings, and described in thefollowing specification are simply exemplary examples of the inventiveconcepts defined in the appended claims. Hence, specific dimensions andother physical characteristics relating to the examples disclosed hereinare not to be considered as limiting, unless the claims expressly stateotherwise.

As required, detailed examples of the present invention are disclosedherein. However, it is to be understood that the disclosed examples aremerely exemplary of the invention that may be embodied in various andalternative forms. The figures are not necessarily to a detailed designand some schematics may be exaggerated or minimized to show functionoverview. Therefore, specific structural and functional detailsdisclosed herein are not to be interpreted as limiting, but merely as arepresentative basis for teaching one skilled in the art to variouslyemploy the present invention.

In this document, relational terms, such as first and second, top andbottom, and the like, are used solely to distinguish one entity oraction from another entity or action, without necessarily requiring orimplying any actual such relationship or order between such entities oractions. The terms “comprises,” “comprising,” or any other variationthereof, are intended to cover a non-exclusive inclusion, such that aprocess, method, article, or apparatus that comprises a list of elementsdoes not include only those elements but may include other elements notexpressly listed or inherent to such process, method, article, orapparatus. An element preceded by “comprises . . . a” does not, withoutmore constraints, preclude the existence of additional identicalelements in the process, method, article, or apparatus that comprisesthe element.

As used herein, the term “and/or,” when used in a list of two or moreitems, means that any one of the listed items can be employed by itself,or any combination of two or more of the listed items can be employed.For example, if any assembly or composition is described as containingcomponents A, B, and/or C, the assembly or composition can contain Aalone; B alone; C alone; A and B in combination; A and C in combination;B and C in combination; or A, B, and C in combination.

As used herein, the terms “assistance” and “resistance” may be usedinterchangeably to signify the direction of external torque applied to ajoint that may be perceived as augmenting (making a movement easier,assistance) or harder (resistance).

Neurological deficits, such as those caused by stroke, spinal cordinjury, and cerebral palsy, often lead to reduced walking ability andgait patterns that limit quality of life. Achieving and maintainingindependent mobility for the estimated 17 million individuals withwalking disabilities in the U.S. is a rehabilitation challenge.Currently, standard-of-care treatments are not fully effective inrestoring gait function. Physical therapy, treadmill-based gaittraining, and intensive muscle strengthening programs have demonstratedvariable and often minimal success for gait rehabilitation. Researchsuggests that the type and dosage of standard therapy programs areinsufficient for large sustainable gains.

FIG. 1, for example, depicts a sequence of events that can ultimatelylead to loss of ambulatory ability. Specifically, in some individuals,diminished ankle functionality results from lack of muscle strength andcan lead to elevated energy costs associated with transport that, inturn, leads to reduced physical activities. The reduced physicalactivities lead, in turn, to secondary health issue, muscle weakness,and reduced gait function leading to loss of ambulatory function. FIG. 2is a chart depicting reductions in steps taken for individuals havingmuscle control disorders as compared to individuals without musclecontrol disorders according to some examples. For children with cerebralpalsy (CP), for example, walking can be drastically more energeticallyexpensive than for their typically developing peers. Muscle strength andendurance do not increase in proportion to body mass during growth,which can contribute to declining walking ability. The ability to walkis related for physical health and general well-being across thelife-span. Reduced level of weight-bearing physical activity contributesto a wide range of secondary conditions associated with CP, such asmetabolic dysfunction, cardiovascular disease, fatigue, weakness,osteoporosis, and chronic pain.

Robotic-assisted gait rehabilitation has grown in application forneurological conditions, however, results of laboratory-based robotictreatments on gait recovery vary. Wearable assistive devices (i.e.powered orthoses) offer potential improvements in gait rehabilitationoutcomes and meet the increasing demand for therapy from the aging U.S.population.

Despite the potential for exoskeleton devices to revolutionize gaitrehabilitation, there are several remaining challenges that must beaddressed, particularly in regards to how they interact with the user.For example, most exoskeleton devices have not been specificallydesigned to engage the user, and have therefore been largelyunsuccessful in improving outcomes over traditional therapies. In otherwords, existing exoskeleton device control strategies are not tailoredto the individual, nor encourage active participation. To improveefficacy, exoskeleton device assisted rehabilitation will benefit fromincreased active engagement during task-specific training. Enhancinguser engagement during robot-assisted tasks can be improved by trackinguser performance over-time and providing real-time performance feedback.

Additionally, current rehabilitation techniques for stroke survivors andpatients with Parkinson's disease are insufficient in effectivelyrestoring gait function. New treatment strategies are needed that willallow for increased dosage of targeted therapy. Recently, it has beendemonstrated that repeated cadence training via stationary cyclingmachines can improve gait and other functional outcomes in these patientpopulations. The various embodiments of this disclosure, combined withadvances in electromechanical actuation, offers the potential forimplementing similar task-specific training via light-weight roboticdevices that can be worn by patients outside of the laboratory. Further,musculoskeletal models can identify the underlying mechanisms of anindividual's gait deficit and may be used to provide targeted roboticrehabilitation that improves outcomes.

By improving walking economy, individuals with gait deficits may engagein greater amounts of habitual physical activity. This may prolongwalking ability and have many additional physical and mental healthbenefits, such as increasing muscle and bone mass. Additionally,increased daily activity would likely also have rehabilitation relatedbenefits, including maintenance or improvement of baseline walkingability, by increasing muscle strength and coordination.

The following disclosure describes device and methods of utilizing theexoskeleton device to provide powered assistance designed to increasemobility or facilitate rehabilitation in a user. The powered exoskeletondevice is a wearable, mobile device that allows a user to perform limbmotions with additional external power, for increasing a user's strengthor endurance. The powered exoskeleton device may operate specifically tofacilitate rehabilitation, providing resistance for targeted andfunctional strengthening. The device may also operate specifically toincrease mobility, providing assistance, aim to enhance or augment theuser's capabilities. The exoskeleton device may be used during dailylife and may offer a transformative new option for improving mobility byreducing barriers to physical activity, such as for individuals withneurologically-based gait disorders. The barriers to mobility faced byindividuals (e.g. individuals with gait deficits) may includeprohibitively high metabolic cost of transport and difficulty completingstrength- and balance-intensive weight-bearing tasks such as navigatingstairs and around or over obstacles. For improving gait mechanics andwalking efficiency, robotic joint (e.g. ankle, knee, hip, and/or anyother joint) actuation can provide positive power to the body throughappropriately-timed assistance (e.g. extension/contraction assistance).For increasing functional strength, robotic joint actuation may resist amovement or targeted muscle group, including powered resistance that isproportional to the instantaneous demand on the joint (i.e. net musclemoment).

The wearable exoskeleton device offers new methods for improving walkingability. For example, the exoskeleton device provided herein may includetechniques (e.g. real-time biofeedback) to encourage favorable changesin volitional muscle activity patterns.

The ankle joint plays a critical role in whole-body stability andforward propulsion during walking. Dynamic ankle actuation and stabilitycontrol are required for independent and effective function at home andin the community. Assistance at or near the ankle joint appears toprovide improvement in walking economy and has the potential to reducethe metabolic cost of transport. Likewise, dynamic or intermittentactuation and stability of a knee joint can also be required, which maybe improved by providing assistance at or near the joint. Othermovements of the body may likewise be improved by providing assistancenear various other joints of the body. This type of powered assistancemay seek to maintain and ultimately augment the wearer's range of motionand muscle strength. Furthermore, by offering the potential to reducethe metabolic cost of activity (e.g. walking), powered joint assistancemay lead to increases in habitual physical activity.

In some embodiments, for improving gait mechanics and walkingefficiency, robotic actuation can provide positive power to the bodythrough appropriately-timed assistance (e.g. plantar-flexion assistance)during the walking process.

For improving performance during balance-intensive tasks, an exoskeletondevice (e.g. an ankle exoskeleton device) can respond rapidly toperturbations or abrupt changes in posture by modulating joint torque,and therefore joint impedance, in real-time, to help maintain balance.

In some embodiments, the present exoskeleton device may provideassistance during some modes of operation intended to improve mobilityor posture in the form of linear force and/or rotational force (i.e.torque). Alternatively, the exoskeleton may provide resistance a mode ofoperation designed to increase muscle recruitment during a function task(e.g. walking) in the form of linear force and/or rotational force (i.e.torque). The assistance or resistance may be provided to various hingedassemblies of the exoskeleton device. The electronic assistance may beprovided by a powered ankle-foot orthosis (AFO), a knee assembly, and/orany other joint assembly that is coupled with a control unit through atransmission assembly. For example, FIGS. 3-6 illustrate variousembodiments of the exoskeleton device 10 that includes a control unit12, a transmission assembly 14, and a pair of hinged assemblies 16. Inthe illustrated embodiment, the exoskeleton device 10 includes two lowerhinged assemblies 16 for a right foot and a left foot of a user. Each ofthe lower hinged assemblies 16 is configured as an AFO.

In some embodiments, the exoskeleton device 10 may also include afeedback modality 18 for providing feedback regarding the individual'suse of a wearable exoskeleton device 10 in a free-living environment. Insome instances, a method for providing feedback to an individual using aprosthesis utilizes a computer monitor mounted at line-of-sight in frontof a treadmill that provides a near real-time visual display of desiredbiomechanical parameters and the individual's compliance ornon-compliance with these parameters. However, as can readily bedetermined, this type of feedback can be incompatible with use outsideof a rehabilitation facility and in free-living settings. Accordingly,in some embodiments, the exoskeleton device 10 may utilize other methodsfor providing feedback that include auditory feedback via speakers orheadphones or earbuds, vibrotactile feedback via small vibrationactuators, and/or wearable visual feedback via body-warn displays (e.g.wrist mounted monitor or LEDs).

In the embodiment illustrated in FIGS. 3-6, the control unit 12 includesattachment straps 20 used to attach the control unit 12 to an individualor a user (e.g. along a user's back). In some examples, the straps 20may include first and second vertical straps along with a waist strap.Any of the straps 20 may be attached to one another on one or both endportions thereof. Moreover, the waist strap may include a buckle 22 thatallows for engagement of two end portions of the strap and adjustabilityas to the length of the strap 20. The straps 20 may be flexible orrigid. The attachment straps 20 may additionally or alternatively be ofa waist strap form, a backpack form, or any other structure forsupporting weight on the user's waist, torso, or other attachment site.

In the embodiment of FIGS. 3-6, the attachment straps 20 are operablycoupled to a base plate 24. The base plate 24 may provide a surface formounting or supporting components of the control unit 12 such as ahousing shell 26, which may serve to cover or protect internalcomponents of the control unit 12 from direct view or interference. Thehousing shell 26 may include be formed from covering material (e.g.plastic, aluminum, cloth) suitably arranged to cover the control unit 12and can have any design disposed thereon. The base plate 24 may becoupled to the housing shell 26 by a plate-to-housing attachment feature28. This plate-to-housing attachment feature 28 may include correspondengagement features and/or removable fasteners, with examples includingbolts, magnets, clips, and slots. In some embodiments, the base plate 24and the housing shell 26 may be embodied as an integral component, whichmay include a single piece or multiple pieces.

The control unit 12 may include one or more actuators 30 that can besupported on the actuator base plate 24. The one or more actuators 30may generate force through a rotary electric motor, linear electricmotor, hydraulic piston, pneumatic piston, pneumatic bladders,combinations thereof, and/or any other device capable of generating aforce. The one or more actuators 30 are coupled to the base plate 24through one or more brackets. The one or more actuator brackets 32 maybe formed from a metallic, polymeric, or other suitable material forsecuring the one or more actuators 30 to the base plate 24. A top plate34 may be positioned on an opposing side of the one or more actuators 30from the base plate 24. The one or more actuator brackets 32 may attachto the base plate 24, the one or more actuators 30, or to the top plate34 through removable or non-removable fasteners (e.g., bolts, clips,slots).

Actuator wiring 36 may electrically couple with the one or moreactuators 30 and is configured to carry electrical power or electricalcontrol signals to and from the one or more actuators 30 to a circuitboard 38 and/or components thereof. The one or more circuit boards 38may include one or more printed circuit boards (PCBs), mounting one ormore circuits or chips, for performing one or more functions describedherein. The one or more circuit boards 38 may be removably ornon-removably coupled to the top plate 34 through fasteners, such asbolts, clips, slots, or other fasteners. In an alternate embodiment, theone or more circuit boards 38 may be coupled to one or more othercomponents within the control unit 12.

The circuit board can include various electrical components, such asmemory, processors, controllers, transceivers, and/or any other device.The various electrical components may have power supplied thereto by oneor more batteries that are also supported by the control unit. Forexample, in the embodiment illustrated in FIGS. 3-6, one or morebatteries 40 are coupled to the top plate 34, to the circuit board 38,or to any other component of the control unit 12 by removable ornon-removable attachments (e.g. brackets or bolts). The one or morebatteries 40 may be any device capable of storing and deliveringelectrical power, with examples including nickel cadmium, nickel metalhydride, lithium ion, lead acid, alkaline, lithium batteries, and so on.The one or more batteries 40 may be rechargeable or single use. Thecontrol unit 12 may further include circuitry and components forconnecting and rectifying external electrical power received fromexternal sources to recharge the one or more batteries 40, in someembodiments.

The first actuator can include a first shaft extending therefrom and thesecond actuator includes a second shaft extending therefrom, the firstand second shafts extending in substantially opposing directions withinthe control unit. Each actuator can be coupled to one or more pulleys orother devices for assisting in translating movement of the actuator to amovement in a different direction. For example, in the embodimentillustrated in FIGS. 3-6, one or more actuator pulleys 42 aredouble-wrap side-hole pulleys. The pulleys 42 are generally axiallyaligned with a shaft 44 of the actuator 30 and rotates in conjunctionwith each respective actuator 30. In some embodiments, the one or moreactuator pulleys 42 may be any suitable device for transferring forcefrom the one or more actuators 30 to a transmission assembly 14.

The force generated by the one or more actuators can be carried by oneor more transmission elements of the transmission assembly. Thetransmission elements are configured to provide force to variouselements of the exoskeleton device that can be remote from the controlunit. For example, cams, linear shafts, pistons, universal joints, andother force-transferring linkages may be implemented. In embodimentillustrated in FIGS. 3-6, the transmission assembly 14 includes one ormore extension cables 46 and one or more contraction cables 48. Theextension cables 46 and contraction cables 48 may be arranged totransfer opposing forces due to the suitability of cables fortransferring “pulling” forces but not for transferring “pushing” forces.In some embodiments, a single transmission element may be used totransfer opposing (both pushing and pulling) forces.

In the embodiment of FIGS. 3-6, the transmission assembly 14 is routeddown one or more legs of a user to reach the lower hinged assembly 16.In the illustrated example, the transmission assembly 14 is lightweightand flexible so as to allow minimal impediment of motion of the knee andhip joints of a user. The AFO may include one or more lubricating fluidsor materials, disposed on an element or between two relatively-movingelements to reduce friction and increase efficiency. The extensioncables and contraction cables may be formed from any suitable material,with examples including metal, Kevlar, and nylon.

The one or more extension cables and one or more contraction cables mayeach be housed in a cable sheath. The one or more cable sheaths mayserve to support and house the extension cables and contraction cables.In the embodiment illustrated in FIGS. 3-6, the extension cables 46 andcontraction cables 48 may be Bowden cables that transfer force via themovement of inner cables relative to a hollow sheath 50 or housingcontaining the inner cable. The one or more cable sheaths 50 may each becoupled to barrel adjustors 52. The barrel adjustors 52 allow foradjustment of the length of the sheaths 50 to adjust a baseline tensionof the extension cables 46 or contraction cables 48. The one or morebarrel adjustors 52 may be further coupled to the one or more cablebrackets.

In the embodiment illustrated in FIGS. 3-6, each lower hinged assembly16 includes an upright member 54 that serves as a mounting or supportelement for the components of the lower hinged assembly 16. Each uprightmember 54 may be additionally coupled to an orthotic cuff 56. Theorthotic cuff 56 may be additionally coupled to a D-ring strap 58 and aVelcro strap 60. The orthotic cuff 56, D-ring strap 58, and Velcro strap60 may be considered together as an attachment mechanism for couplingthe lower hinged assembly 16 to a leg of a user at an attachment site,which may be between an ankle and a knee of the leg of the user.

Each upright member 54 may be additionally coupled to a bearing 62 orjoint proximate an opposing end portion from the orthotic cuff 56. Theone or more bearings 62 may each be coupled to a sprocket 64. Each ofthe one or more bearings 62 may serve as a freely-rotating andload-bearing connection between the upright member 54 and the sprocket64. Each collection of an upright member 54, a sprocket 64, and abearing 62 may be operably coupled to one another through connectinghardware, such as bolts and nuts or other suitable connecting hardware.The connecting hardware may be disposed through various adjustment holesdefined by the upright member 54 for adjustability of the lower hingedassembly 16 based on the user's body type.

In some embodiments, additional brackets are attached to the lowerhinged assembly based on the joint that is to be assisted. For example,as illustrated in FIGS. 3-6, one or more insole brackets 66 may berotatably coupled with the upright member 54. The insole brackets 66support the foot of the user and received torque that is to be appliedto a walking surface of the user. The one or more insole brackets 66 maybe formed from a metallic material, a polymeric material, and/or anyother suitable rigid material. The one or more insole brackets 66 may beconfigured to be inserted into a user's footwear using thin elementswithout external straps.

The cable sheaths 50 may be coupled to the lower hinged assembly 16 bylower barrel adjusters 68 to anchor the lower end portions thereof. Thelower barrel adjustors 68 may provide adjustment of the length of thesheaths 50 thereby providing adjustment of the baseline tension of theextension cables 46 or contraction cables 48. The one or more barreladjustors 68 may be mounted on a support block 70. The one or moresupport blocks 70 may each be additionally coupled to the upright member54.

After passing through the barrel adjusters 68 and exiting their sheaths50, the extension cables 46 and the contraction cables 48 may couple tothe sprockets 64. The sprockets 64 may clamp to each of the extensioncables 46 and the contraction cables 48 on a first end portion andcoupled to a single actuator pulley 42 in the control unit 12 on asecond end portion. In various embodiments, an opposing pair may insteadembodied in a single element with the capability to transfer bothpositive and negative forces. In some embodiments, the sprocket 64 mayinclude any device for capturing force from a transmission assembly 14to produce torque between two or more attachment points with at leastone attachment point on each side of a user's joint (e.g., torquebetween the insole bracket 66 and the orthotic cuff 56).

Each upright member 54 and insole bracket 66, taken in combination, maybe considered as a force-applying arm applying torque around an axis. Insome instances, the axis is generally aligned with a body joint axis(e.g. an ankle joint axis). When a force is applied along a length ofextension cables 46 or contraction cables 48, a force is applied tosprocket 64 and, in turn, insole bracket 66. Accordingly, the forcesapplied along the lengths of extension cables 46 and contraction cables48 apply a force causing insole bracket 66 to rotate about the bearing62 with respect to upright member 54.

In various embodiments, the extension cables 46 and/or the contractioncables 48 can be actuated based on acquired data from one or moresensors 72 within the exoskeleton device 10 in reference to use of thehinged assembly. As provided herein, one or more performance metrics maybe determine based on the acquired data, which may include at least oneof a posture position, joint positions/angles, joint moment, jointpower, or spatiotemporal parameters of walking, including step/stridelength and gait speed. In some examples, the one or more sprockets 64may each be additionally coupled to a torque sensor 74 or a joint angleencoder configured to measure an angle at some point during anindividual's gait cycle as the data point. The torque sensor 74 may beused to sense the torque force applied by the exoskeleton device 10 forassistance. The torque sensor 74 may be additionally coupled to theinsole bracket 66. In some embodiments, the one or more sprockets 64 maybe coupled to the corresponding one or more insole brackets 66 withoutan intermediate torque sensor 74. Additionally or alternatively, invarious embodiments, the sensor 72 may be configured as one or moreaccelerometers coupled the lower hinged assembly 16 to provideinformation on the user's gait.

In some embodiments, the sensor 72 may be configured as one or morepressure/force sensors 76 may also be operably coupled with the insolebracket 66. The one or more pressure/force sensors 76 may be positionedon an upwardly and/or a downwardly facing surface of the insole bracket66 in various embodiments to provide spatial pressure information acrossthe foot surface. The one or more pressure/force sensors 76 may includeforce-sensitive resistors, piezoresistors, piezoelectrics, capacitivepressure sensors, optical pressure sensors, resonant pressure sensors,or other means of sensing pressure, force, or motion.

The control unit containing the circuit board may include variouselectrical components for actuating one or more of the actuators 30. Inturn, the actuators 30 provide force that is transmitted to one or moreupper or lower hinged assemblies through the transmission assembly. Inthe embodiment illustrated in FIG. 7, the control unit 12 includes acontroller 78 having a processor 80 and memory 82 that is powered by thepower supply. Logic 84 is stored within the memory 82 and includes oneor more routines that is executed by the processor 80, such as themethod 106 described in reference to FIG. 10 and/or the method 120described in reference to FIG. 11. The controller 78 includes anycombination of software and/or processing circuitry suitable forcontrolling various components of the exoskeleton device 10 describedherein including without limitation processors, microcontrollers,application-specific integrated circuits, programmable gate arrays, andany other digital and/or analog components, as well as combinations ofthe foregoing, along with inputs and outputs for transceiving controlsignals, drive signals, power signals, sensor signals, and so forth. Allsuch computing devices and environments are intended to fall within themeaning of the term “controller” or “processor” as used herein unless adifferent meaning is explicitly provided or otherwise clear from thecontext.

In some examples, more than one joint on a common limb may be assistedby the exoskeleton device and activated/deactivated by the controller.For example, in some instances, the exoskeleton device may provideassistance to any one or more of an ankle, a knee, and/or a hip of auser. In the embodiment of FIG. 7, the exoskeleton device 10 includesthe control unit 12, a pair of upper hinged assemblies 16 a and a pairof lower hinged assemblies 16 b. The pair of upper hinged assemblies 16a may be positioned proximately to respective knees of a user while thelower hinged assemblies 16 b may be positioned proximately to the user'srespective ankles. In some examples, the exoskeleton device 10 mayinclude any number of upper hinged assemblies 16 a and/or lower hingedassemblies 16 b depending on the assistance to be provided to the user.

In the embodiment illustrated in FIG. 7, the control unit 12 includesfour actuators 30 that respectively control one of the upper and/orlower hinged assemblies 16 a, 16 b. In some embodiments, a firstactuator 30 can provide a first level of assistance and the secondactuator 30 can provide a second level of assistance. The first level ofassistance can be greater than, equal to, or less than the second levelof assistance during different phases in which the exoskeleton device 10is used.

In some instances, a transmission may include various gear ratios thatallow for more than one upper or lower hinged assembly 16 a, 16 b to becontrolled by a common actuator 30. The actuators 30 may be disposed inan offset relationship from one another such that the transmissionassemblies 14 extending from each of the actuators 30 towards the upperor lower hinged assemblies 16 a, 16 b and free of contact from oneanother within the control unit 12. It will be appreciated that theupper and lower hinged assemblies 16 a, 16 b illustrated in FIG. 7 mayinclude any of the components described herein.

The control unit 12 may further include a display 94 for providing thestatus of the operation of the exoskeleton device 10 and/or operationaldata. The control unit 12 may further include an input device 90 foraccommodating various user inputs and/or a speaker 92, which may also beoperably coupled with the control unit 12, for notifying a user of anydesired condition.

As provided herein, any of the upper and lower hinged assemblies 16 a,16 b can include any type of sensor 72, which may communicate with thecontrol unit 12 in a wired and/or wireless manner. For example, like thelower hinged assemblies 16 b, the upper hinged assemblies 16 a may alsoinclude a torque sensor 74. The torque sensor 74 may be used to sensethe torque force applied by the exoskeleton device 10 for assistance.Additionally or alternatively, in various embodiments, one or moreaccelerometers may be coupled to the upper and/or lower hingedassemblies 16 a, 16 b to provide information on the user's gait.Additionally, angle sensors along the exoskeleton device 10 can measurevarious angles during a gait cycle and may include potentiometers,encoders (e.g., optical encoders), and the exoskeleton device 10employing a light source and a light detector capable of calculating anangle of the exoskeleton device 10. Sensors such as inertial measurementunits (IMUS) may also be used to determine acceleration, velocity,position, and orientations on one or more segments of the exoskeletondevice 10 or biological limbs.

In some examples, the exoskeleton device 10 may communicate via wiredand/or wireless communication with the feedback modality 18 and/or oneor more handheld or electronic devices 86 through a transceiver 88. Thecommunication may occur through one or more of any desired combinationof wired (e.g., cable and fiber) and/or wireless communicationmechanisms and any desired network topology (or topologies when multiplecommunication mechanisms are utilized). Exemplary wireless communicationnetworks include a wireless transceiver 88 (e.g., a BLUETOOTH module, aZIGBEE transceiver, a Wi-Fi transceiver, an IrDA transceiver, an RFIDtransceiver, etc.), local area networks (LAN), and/or wide area networks(WAN), including the Internet, cellular, satellite, microwave, and radiofrequency, providing data point communication services.

The electronic device 86 may be any one of a variety of computingdevices and may include a processor and memory. The memory may storelogic having one or more routines that is executable by the processor.For example, the electronic device 86 may be a cell phone, computer,mobile communication device, key fob, wearable device (e.g., fitnessband, watch, glasses, jewelry, wallet), apparel (e.g., a tee shirt,gloves, shoes or other accessories), personal digital assistant,headphones and/or other devices that include capabilities for wirelesscommunications and/or any wired communications protocols. The electronicdevice 86 may have an application 91 thereon and a display 95 mayprovide a graphical user interface (GUI) and/or various types ofinformation to a user. The operation of the various components of theexoskeleton device 10 may be altered through the usage of theapplication 91 and/or information regarding the operation of thecomponents may be provided on the display 95. The electronic device 86may likewise have any combination of software and/or processingcircuitry suitable for controlling the exoskeleton device 10 describedherein including without limitation processors, microcontrollers,application-specific integrated circuits, programmable gate arrays, andany other digital and/or analog components, as well as combinations ofthe foregoing, along with inputs and outputs for transceiving controlsignals, drive signals, power signals, sensor signals, and so forth.

In some embodiments, the electronic device 86 may be configured toreceive user inputs via the input circuitry 93. For example, the inputsmay relate to an amount of assistance to be provided by the exoskeletondevice 10 or any other information and/or commands. In response, thecontroller 78 may activate/deactivate the one or more actuators 30 toproduce force equating to the desired amount of assistance. Accordingly,usage of the exoskeleton device 10 may be varied through the usage ofthe application 91 in addition to or in lieu of usage of the inputdevice 90. Additionally or alternatively, the electronic device 86 mayalso provide feedback information, such as visual, audible, and tactilealerts. The feedback information may be provided for any reason,including but not limited to, additional assistance being needed, lessassistance being needed, a set number of cycles being reached, apredefined goal being accomplished, etc. The feedback information may beat least partially determined by the sensors 72, which may include bytorque sensors 74, pressure/force sensors 76, and/or any other sensorwithin the exoskeleton device 10.

In some embodiments, the controller 78 operates a finite state machineto control the operation of the actuators 30 to provide assistance to auser. For example, the state machine implemented by the controller 78may define a number of different states, including early stance, latestance, and swing phases of the user's gait or step cycle that, in turn,control which of the actuators 30 is operated to apply force to eitherextension cables 46 (FIG. 3) or contraction cables 48 (FIG. 3) toprovide force assistance to the wearer. For example, when a pullingforce is applied to a lower hinged assembly 16 b by extension cables 46through the actuators 30, a torque is applied to the sprocket 64 (FIG.3) causing the insole bracket 66 (FIG. 3) to be rotated downwards withrespect to the upright member 54 (FIG. 3) thereby assisting the user inmoving their toes downwards (i.e., extension). Conversely, when apulling force is applied to contraction cables 48 by actuators 30, atorque is applied to sprocket 64 causing the insole bracket 66 to berotated upwards with respect to the upright member 54 thereby assistingthe user in moving their toes upwards (i.e., contraction). In thismanner, the upright member 54 and the insole bracket 66 operate as firstand second arms of a hinged connection at the user's joint. The firstarm of the hinge (e.g., the upright member 54) is fixed to the user'slimb (e.g. by orthotic cuff 56 around the lower leg), while the secondarm of the hinge (e.g., insole bracket 66) is positioned along a user'sfoot. Similarly, the actuators 30 may assist in extension andcontraction of the upper hinged assembly 16 b proximate to a user's kneeto provide assistance to such joints during various portions of the gaitcycle.

The state machine may receive input from one or more sensors 72, and usecurrent and previous input values in order to determine a current stateof the state machine. The current state is then used to determine thetiming of the actuator 30 activation, in order to provide torqueassistance to the user with appropriate timing and intensity (e.g., toprovide extension assistance during toe-off, or contraction assistanceduring foot swing to prevent drop foot).

In some embodiments, the feedback modality 18 provides feedbackregarding the individual's use of a wearable exoskeleton device 10 in afree-living environment. Various types of feedback mechanisms (e.g.,auditory, visual, electro-tactile, vibro-tactile) and various locationsof placement (e.g., leg, arm, torso, within the control unit 12) aresuited for providing performance tracking during exoskeleton device 10assisted walking. In some examples, the feedback modality 18 may includesmall vibratory actuators may be used to provide vibro-tactile feedback.Additionally or alternatively, the feedback modality 18 may includeelectrical stimulation that may be used to provide electro-tactilefeedback. Additionally or alternatively, the feedback modality 18 mayinclude an LED array or other visual display that may be used to providecolor-coded visual feedback. Additionally or alternatively, the feedbackmodality 18 may include feedback utilizing one or more of wired orwireless (e.g., Bluetooth) headphones or a small piezo speaker thatmodulates a beep frequency to provide auditory signals to theindividual. Each of the above feedback modalities may be used at logicalbody placements, which includes possible locations on the leg, hip,torso, and wrist. For example, vibro-tactile and electro-tactilefeedback may be suitable for several different locations, while visualfeedback may be suitable on locations that are easily seen by theindividual user, such as the wrist.

In some embodiments, the controller 78 may provide instructions to aparticular feedback modality 18 based on the input received from any ofthe embedded sensors 72. For example, the torque sensor 74 (or any othersensor) may be configured to measure an angle θ shown in FIG. 8 duringthe swing phase of an individual's gait. If the angle θ is not reachingthe desired value, then the controller 78 activates a feedback modality18 to inform the individual that they are not complying with the desiredperformance data point. The feedback modality 18 could include one ormore of the various types of feedback described herein (tactile, visual,and auditory).

Additionally, compliance with a desired performance data point may alsotrigger a feedback modality 18 to inform the individual that they areindeed in compliance, or, the feedback modality 18 could inform theindividual of both compliance and noncompliance. For example, if, in theabove example, the modality contains both green and red light sources,the green light source is illuminated if the angle θ reaches the desiredvalue, and the red light source is illuminated if the angle θ is doesnot reach the desired value. Electromyography may be used to measure thecompliance of specific muscles or muscle groups and relay thisinformation through the feedback modality 18. Likewise, the feedbackmodality 18 may provide a first sound from a speaker or within thecontrol unit 12 or the feedback modality 18 when a user is in compliancewith the performance data point and a second sound when the user is notin compliance with the performance data point. Additionally, sounds maybe generated when other conditions are obtained and/or are not obtained.

The feedback modality may also be used in combination with gamificationto enhance the experience of gait rehabilitation and to further engageand incentivize the individual with the feedback process. Non-limitingexamples include a scoring system based on collecting points, coins, orother rewards based on rehabilitation progress customized to theindividual. The application on the electronic device may be designed toallow the individual to play outside of the rehabilitation setting. Theapplication may also be connected to an individual's physicaltherapist's (or other advisor's) database or electronic device to reportprogress or may connect to other systems for using the exoskeletondevice in a social or competitive context. For example, in the exampleillustrated in FIG. 9, the exoskeleton device 10, the electronic device86, and/or the feedback modality 18 may be communicatively coupled withone or more remote sites such as a remote server 96 via a network/cloud98.

The network/cloud 98 represents one or more systems by which theexoskeleton device 10, the electronic device 86, and/or the feedbackmodality 18 may communicate with the remote server 96. Accordingly, thenetwork/cloud 98 may be one or more of various wired or wirelesscommunication mechanisms, including any desired combination of wiredand/or wireless communication mechanisms and any desired networktopology (or topologies when multiple communication mechanisms areutilized). Exemplary communication networks 172 include wirelesscommunication networks (e.g., using Bluetooth, IEEE 802.11, etc.), localarea networks (LAN) and/or wide area networks (WAN), including cellularnetworks, satellite networks, microwave networks, radio frequencynetworks, the Internet and the Web, which all may provide databasecommunication services and/or cloud computing services.

The Internet is generally a global database communications system thatis a hardware and software infrastructure, which provides connectivitybetween computers. In contrast, the Web is generally one of the servicescommunicated via the Internet. The Web is generally a collection ofinterconnected documents and other resources, linked by hyperlinks andURLs. In many technical illustrations when the precise location orinterrelation of Internet resources are generally illustrated, extendednetworks such as the Internet are often depicted as a cloud (e.g. 98 inFIG. 9). The verbal image has been formalized in the newer concept ofcloud computing. The National Institute of Standards and Technology(NIST) provides a definition of cloud computing as “a model for enablingconvenient, on-demand network access to a shared pool of configurablecomputing resources (e.g., networks, servers, storage, applications, andservices) that can be rapidly provisioned and released with minimalmanagement effort or service provider interaction.” Although theInternet, the Web, and cloud computing are not exactly the same, theseterms are generally used interchangeably herein, and they may bereferred to collectively as the network/cloud 98.

The server 96 may be one or more computer servers, each of which mayinclude at least one processor and at least one memory, the memorystoring instructions executable by the processor, including instructionsfor carrying out various steps and processes. The server 96 may includeor be communicatively coupled to a data store 100 for storing collecteddata point as well as instructions for operating the exoskeleton device10, the feedback modality 18, the electronic device 86, etc. that may bedirected to and/or implemented by the exoskeleton device 10, theelectronic device 86, and/or the feedback modality 18 with or withoutintervention from a user and/or the electronic device 86.

In some examples, the instructions may be inputted through theelectronic device 86 and relayed to the server 96. Those instructionsmay be stored in the server 96 and/or data store 100. At variouspredefined periods and/or times, the exoskeleton device 10 and/or thefeedback modality 18 may communicate with the server 96 through thenetwork/cloud 98 to obtain the stored instructions, if any exist. Uponreceiving the stored instructions, the exoskeleton device 10 and/or thefeedback modality 18 may implement the instructions. The server 96 mayadditionally store information related to multiple exoskeleton devices10 and operate and/or provide instructions to the exoskeleton device 10,the feedback modality 18, and the electronic device 86 in conjunctionwith the stored information with or without intervention from a user.The information may include performance data point from a wide array ofusers.

With further reference to FIG. 8, the server 96 also generallyimplements features that may enable the exoskeleton device 10 and/or thefeedback modality 18 to communicate with cloud-based applications 102.Communications from the exoskeleton device 10 and/or the feedbackmodality 18 can be directed through the network/cloud 98 to the server96 and/or cloud-based applications 102 with or without a networkingdevice 104, such as a router and/or modem. Additionally, communicationsfrom the cloud-based applications 102, even though these communicationsmay indicate one of the exoskeleton device 10 and/or the feedbackmodality 18 as an intended recipient, can also be directed to the server96. The cloud-based applications 102 are generally any appropriateservices or applications 102 that are accessible through any part of thenetwork/cloud 98 and may be capable of interacting with the exoskeletondevice 10 and/or the feedback modality 18.

In various examples, the electronic device 86 can be feature-rich withrespect to communication capabilities, i.e. have built-in capabilitiesto access the network/cloud 98 and any of the cloud-based applications102 or can be loaded with, or configured to have, such capabilities. Theelectronic device 86 can also access any part of the network/cloud 98through wired or wireless access points, cell phone cells, or networknodes. In some examples, users can register to use the remote server 96through the electronic device 86, which may provide access theexoskeleton device 10 and/or the feedback modality 18 and/or therebyallow the server 96 to communicate directly or indirectly with theexoskeleton device 10 and/or the feedback modality 18. In variousinstances, the exoskeleton device 10 and/or the feedback modality 18 mayalso communicate directly, or indirectly, with the electronic device 86or one of the cloud-based applications 102 in addition to communicatingwith or through the server 96. According to some examples, theexoskeleton device 10 and/or the feedback modality 18 can bepreconfigured at the time of manufacture with a communication address(e.g. a URL, an IP address, etc.) for communicating with the server 96and may or may not have the ability to upgrade or change or add to thepreconfigured communication address.

Referring still to FIG. 9, when a new cloud-based application 102 isdeveloped and introduced, the server 96 can be upgraded to be able toreceive communications for the new cloud-based application 102 and totranslate communications between the new protocol and the protocol usedby the exoskeleton device 10 and/or the feedback modality 18. Theflexibility, scalability, and upgradeability of current servertechnology render the task of adding new cloud-based applicationprotocols to the server 96 relatively quick and easy.

In some examples, wearable assistance system includes the exoskeletondevice 10, the feedback modality 18, the electronic device 86, and/or ameasurement device. The measurement device is configured to generatebiomechanical data point of an individual. The collected data point canthen be used to determine an individual's gait deficits. The controller78 of the exoskeleton is configured to actuate the actuator 30 at aninitial level of assistance based on the gait deficits. In variousexamples, the measurement device is a motion capture camera configuredto detect movement and force gait analysis. Additionally oralternatively, the measurement device utilizes a measurement of muscleactivity through electromyography. Additionally or alternatively, themeasurement device utilizes a measurement of oxygen consumption/CO2production to determine a metabolic rate. The generated biomechanicaldata point of the individual can be compared to a computer-generatedmodel of a gait cycle.

In some embodiments, a method of initially defining a musculoskeletalmodel may be used to help inform the design of personalized assistivedevices. The computer-generated musculoskeletal model is based on theresults obtained by any one or more of a detailed biomechanical, gait,and neuromuscular assessment of an individual. For example, asillustrated in FIG. 10, a method 106 begins at step 108, in whichbiomechanical data point is collected. As non-limiting examples, thecollection of the biomechanical data point can be performed in alaboratory or rehabilitation setting and utilizing a measurement devicemotion capture of movement and force gait analysis via motion capturecameras, a measurement of muscle activity through electromyography,and/or a measurement of oxygen consumption/CO2 production to determine ametabolic rate. Accordingly, one or more of wearable sensors (jointencoders for angle measurement, embedded shoe sensors for groundreaction force measurement, etc.), a motion capture camera (movement andforce gait analysis via motion capture cameras); a measurement devicefor monitoring muscle activity (electromyography, EMG, wirelesselectromyography electrodes); a neuromuscular assessment device (balancetesting device and dynamometer); a measurement device of oxygenconsumption/CO2 production (metabolic rate); and/or any otherpracticable device can be used during the collection of thebiomechanical data point. Based on the data point collected, anindividual that would benefit from a wearable robotic assistance deviceis evaluated.

During the data point collection, the individual may perform a series ofactivities with or without the exoskeleton, including, for example,walking on a treadmill while being filmed with the motion capturecameras and having their muscle activity and oxygen consumptionmeasured. The individual may also undergo a neuromuscular assessment.This baseline analysis of an individual's gait and motion estimates themuscle forces in either a total sum of muscle forces or single muscles,modeled as individual lines of action.

Based on the biomechanics data point collected at step 108, anindividualized musculoskeletal (computer-generated) simulation isdeveloped for each individual in order to inform the design of thepersonalized assistive devices at step 110. In some embodiments of themethod illustrated in FIG. 10, each individual's gait deficits and thecontributing mechanisms are determined by comparing the results of theindividualized musculoskeletal simulations to simulations of healthyindividuals at step 112. The comparative data point may be generatedduring data point collection on other individuals within the lab and/orthrough data point compilation of the exoskeleton device 10 usage byother individuals that is stored/obtained through the network/cloud 98.In such instances, the data point may be dynamically updated based onthe addition of new data point. However, in some embodiments, step 112may be replaced by a computer-generated model or not needed altogether.

Next, at step 114, predictive simulations are created by modeling theeffects of exoskeleton device assistance on the individualizedsimulations to inform the design and control of each individual'sexoskeleton device 10. The predictive simulation provides an initialforecast of the individual's gait with the exoskeleton deviceassistance. In some instances, this simulation can significantly reducethe individual's customization time, which may be beneficial as manypatients may be easily exhausted by testing and adjustment of theexoskeleton device 10.

The predictive simulations of step 114 provide the optimized designparameters, which at step 116 are implemented in the individualizedrobotic wearable exoskeleton device 10. The optimized design parametersset an initial assistance level at each hinged assembly 16 for the userof the exoskeleton device 10. Thus, the wearable assistance provided viathe exoskeleton device 10 is tailored to the specific gait deficits ofeach individual. The exoskeleton device 10 can provide a small,calculated amount of electronic assistance that is intended to augmentexisting muscle activity to elicit functional changes at the hip, knee,or ankle joints. While assisting the user during the gait cycle, theuser may still experience instability. Accordingly, in variousembodiments, the exoskeleton device 10 also may implement safetyprecautions to assist in patient safety, including, mechanical “stops”to prevent hyperextension of joints, an emergency stop button that shutsoff power to the device, and embedded software mechanisms that shut offpower if the user were to fall. The safety precautions may also beconnected to the network/cloud 98.

At step 118, the movement of an individual may be monitored to determineif appropriate assistance is being provided. In some embodiments, themonitoring is accomplished through the sensors 72 embedded within theexoskeleton. Additionally and/or alternative, the monitoring may beaccomplished through sensors that are remote to the exoskeleton device10.

In some embodiments, the amount of assistance a user may need mayincrease or decrease over time. For example, as a disease continues, theamount of mobility of a user may decrease, thus, they may need increasedassistance. On the other hand, in some situations, with or without theuse of the exoskeleton device 10, a user may be able to improve theirmobility or strength, thus, may need less assistance over time.Accordingly, the controller can be configured to decrease the level ofassistance or increase resistance when the change in the at least onedata point is indicative of increased performance by an individual usingthe exoskeleton device. Conversely, the controller can be configured toincrease the level of assistance or decrease resistance when the changein the at least one data point is indicative of decreased performance byan individual using the exoskeleton device. To account for possiblechanges in assistance, an exoskeleton device control algorithm capableof establishing and tracking personalized measures of exoskeleton device10 assisted walking performance may be present within the control unit12 (see FIG. 9) and/or located in the server 96, which may be accessedthrough the network/cloud 98. In the example shown in FIG. 11, ahierarchical control strategy is programmed onto the memory (FIG. 7). Asprovided herein, the control strategy utilizes data point from one ormore sensors 72 embedded in the exoskeleton device 10 to track postureand/or other data points, evaluate how these data points change overtime and adjust the level of assistance accordingly.

For example, in the embodiment illustrated in FIG. 11, an example of aclosed loop method 120 for adaptively altering an amount of assistanceis provided. In the embodiment illustrated in FIG. 11, the method beginsat step 122, in which a user's performance is measured by the one ormore sensors 72 embedded within the exoskeleton device 10. In variousexamples, the one or more sensors 72 can be incorporated at the lowerhinged assembly 16 a (FIG. 7) of the exoskeleton device 10 to measurethe forces being applied to the foot, at the upper hinged assembly 16 b(FIG. 7) to measure a degree of rotation of the knee through the gaitcycle, and/or at the hip to measure the kinematics of the hip jointthrough the gait cycle. These measurements can be used to determine thestance versus swing phase of the walking motion. Depending on thespecific gait deficit of the individual, the exoskeleton device 10 mayinclude one or more types of sensors 72 and/or one or more of the sametype of sensor 72.

At step 124, the measured data point is stored in the memory of thecontrol unit 12, in the data store 100 that is remote from theexoskeleton device 10, and/or in the electronic device 86. The storeddata point may be retained in any manner. The stored data point may beaccessed by the control unit 12 of the exoskeleton device 10, thefeedback modality 18, and/or a remote electronic device 86. The remoteelectronic device 86 may be accessed by a remote advisor, such as aphysical therapist, who can, in turn, monitor the usage of theexoskeleton device 10 and/or adjust the assistance level provided by theexoskeleton device 10 remotely. In addition, the electronic device 86may also be a database that compiles the stored data point from one ormore users that can be used for a wide array of analyses and adjustmentsin assistance levels.

At step 126, the method determines if measurement data point regarding aspecific user has previously been stored. If no data point haspreviously been stored, the method returns to step 122 and measuresadditional performance data point. If previous data point has beenstored, the method continues to step 128 in which the most recentlycollected data point is compared to previously obtained data point todetermine when a performance metric has increased. To determine aperformance metric, any of the data points collected by the exoskeletondevice 10 may be used. In some embodiments, the most recently obtaineddata point may be compared to a predefined number of previous cycles.For example, the most recent data point may be compared to 100 (or anyother number of) previous data point acquisition cycles. The comparisonsmay be used to define trends, which in turn, may be used to determine aprolonged performance trend of the user. The prolonged performance trendmay be used for determining whether to adjust the assistance level ofthe exoskeleton device 10.

If the performance metric of the user has increased, the methodcontinues to step 130 in which the amount of assistance or resistanceprovided by the exoskeleton device 10 is adjusted (increased ordecreased). In some embodiments, the method continues to step 132wherein a notification is provided to the user that their performancehas increased by at least a threshold amount, and thus, the amount ofassistance provided will be reduced. The method may then continue backto step 122 to collect the next iteration of data point.

If at step 128 it is determined that the performance metric hasn'timproved by at least a threshold level, the method continues to step134, where the method determines whether the performance data point hasdecreased by a threshold amount. If the performance data point has notdecreased by a threshold amount, then the method continues to step 136where the amount of assistance or resistance provided is maintained.Next, the method returns to step 122 where an additional cycle of datapoint is collected.

If at step 136 it is determined that the performance metric has fallenbelow the threshold level, the method continues to step 138 wherein theamount of assistance provided by the exoskeleton device 10 is increased.Next, the method can continue to step 140, where a notification isprovided to the user and/or another person that the performance datapoint has fallen and that additional assistance or resistance will beadministered. The method then returns to step 122 to collect additionaldata point.

Accordingly, as a non-limiting example of the method, a sensor 72 maymeasure the angle θ during the swing phase of an individual's gait. Ifthe angle θ is not reaching the desired value at a certain level ofassistance, then the controller 78 instructs the actuator 30 to increaseassistance. Conversely, if the angle θ is consistently reaching thedesired value at a given level of assistance, then the controller 78instructs the actuator 30 to gradually decrease the assistance level. Ifthe performance metric is being met within upper and lower bands, theassistance level provided by the exoskeleton device 10 may bemaintained.

Use of the present disclosure may offer a variety of advantages, whichis provided by various combinations of the features provided herein. Forexample, the exoskeleton device provided herein may provide assistanceto any number of joints of a user. Moreover, the assistance orresistance may be provided in a real-world environment, versus just in alab. The exoskeleton may be minimally invasive to the user duringday-to-day activities and manufactured at substantially reduced costscompared to various other assistance devices that are commerciallyavailable. The exoskeleton may provide assistance during some modes ofoperation specifically intended to improve mobility or posture.Additionally or alternatively, the exoskeleton may provide resistance amode of operation designed to increase muscle recruitment during afunction task (e.g. walking). The exoskeleton provided herein may becoupled with a feedback modality that allows for feedback regarding useof the exoskeleton device. For example, the user modality may alert auser when various performance goals are met. In addition, theexoskeleton may be remotes coupled to an electronic device. Theelectronic device may obtain data regarding the exoskeleton deviceand/or provided controls for altering usage of the exoskeleton device.In addition, the exoskeleton device may include one or more algorithmsfor intermittently adjusting the assistance level of the exoskeletondevice based on the user performance. The assistance level may bechanged from an initial assistance level that is obtained throughvarious methods provided herein that make it quicker and more obtainablefor a user with gait deficits to be fitted with the exoskeleton device.

It will be understood by one having ordinary skill in the art thatconstruction of the described invention and other components is notlimited to any specific material. Other exemplary examples of theinvention disclosed herein may be formed from a wide variety ofmaterials unless described otherwise herein.

For purposes of this disclosure, the term “coupled” (in all of itsforms: couple, coupling, coupled, etc.) generally means the joining oftwo components (electrical or mechanical) directly or indirectly to oneanother. Such joining may be stationary in nature or movable in nature.Such joining may be achieved with the two components (electrical ormechanical) and any additional intermediate members being integrallyformed as a single unitary body with one another or with the twocomponents. Such joining may be permanent in nature or may be removableor releasable in nature unless otherwise stated.

Furthermore, any arrangement of components to achieve the samefunctionality is effectively “associated” such that the desiredfunctionality is achieved. Hence, any two components herein combined toachieve a particular functionality can be seen as “associated with” eachother such that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected” or “operablycoupled” to each other to achieve the desired functionality, and any twocomponents capable of being so associated can also be viewed as being“operably couplable” to each other to achieve the desired functionality.Some examples of operably couplable include, but are not limited to,physically mateable, physically interacting components, wirelesslyinteractable, wirelessly interacting components, logically interacting,and/or logically interactable components.

It is also important to note that the construction and arrangement ofthe elements of the invention as shown in the examples are illustrativeonly. Although only a few examples of the present innovations have beendescribed in detail in this disclosure, those skilled in the art whoreview this disclosure will readily appreciate that many modificationsare possible (e.g., variations in sizes, dimensions, structures, shapesand proportions of the various elements, values of parameters, mountingarrangements, use of materials, colors, orientations, etc.) withoutmaterially departing from the novel teachings and advantages of thesubject matter recited. For example, elements shown as integrally formedmay be constructed of multiple parts or elements shown as multiple partsmay be integrally formed, the operation of the interfaces may bereversed or otherwise varied, the length or width of the structuresand/or members or connectors or other elements of the system may bevaried, the nature or number of adjustment positions provided betweenthe elements may be varied. It should be noted that the elements and/orassemblies of the system might be constructed from any of a wide varietyof materials that provide sufficient strength or durability, in any of awide variety of colors, textures, and combinations. Accordingly, allsuch modifications are intended to be included within the scope of thepresent innovations. Other substitutions, modifications, changes, andomissions may be made in the design, operating conditions, andarrangement of the desired and other exemplary examples withoutdeparting from the spirit of the present innovations.

It will be understood that any described processes or steps withindescribed processes may be combined with other disclosed processes orsteps to form structures within the scope of the present invention. Theexemplary structures and processes disclosed herein are for illustrativepurposes and are not to be construed as limiting. In addition,variations and modifications can be made on the aforementionedstructures and methods without departing from the concepts of thepresent invention and such concepts are intended to be covered by thefollowing claims unless these claims by their language expressly stateotherwise.

What is claimed is:
 1. A method of using an ankle exoskeleton device,the method comprising: collecting one or more biomechanical data pointsfrom an individual using wearable sensors or sensors embedded within theexoskeleton device; developing individualized musculoskeletalsimulations based on the one or more biomechanical data points; creatingpredictive simulations by modeling effects of an ankle exoskeletondevice on the individualized musculoskeletal simulations; determininggait deficits by comparing the results of the individualizedmusculoskeletal simulations to data points collected on otherindividuals using the exoskeleton device; and determining a controlalgorithm configured to modify an operation of the exoskeleton devicebased on the predictive simulations and the gait deficits.
 2. The methodof claim 1, wherein the control algorithm utilizes data point from anembedded sensor on the exoskeleton device to track at least one datapoint, evaluates how the at least one data point changes over time, andadjusts a level of assistance provided by the exoskeleton device.
 3. Themethod of claim 1, wherein determining the control algorithm based onthe predictive simulations further comprises: augmenting, using thecontrol algorithm, existing muscle activity to elicit functional changesof the individual through activation of one or more actuators.
 4. Themethod of claim 1, further comprising: assisting the individual during agait cycle through manipulation of the exoskeleton device.
 5. The methodof claim 1, further comprising: resisting the individual during a gaitcycle through manipulation of the exoskeleton device.
 6. A wearableassistance system, comprising: an ankle exoskeleton device comprising: acontrol unit including a controller; and a motor in electricalcommunication with the controller; and a measurement device configuredto generate biomechanical data points of an individual, wherein themeasurement device is configured to determine an individual's gaitdeficits by developing individualized musculoskeletal simulations basedon the biomechanical data points and comparing the results of theindividualized musculoskeletal simulations to data points collected onother individuals using the exoskeleton device and the controller isconfigured to actuate the motor at an initial level of assistance basedon the gait deficits.
 7. The wearable assistance system of claim 6,wherein the generated biomechanical data point of the individual iscompared to a computer-generated model of a gait cycle.
 8. The wearableassistance system of claim 6, wherein the measurement device is a motioncapture camera configured to detect movement.
 9. The wearable assistancesystem of claim 6, where the measurement device utilizes a measurementof muscle activity through electromyography.
 10. The wearable assistancesystem of claim 9, wherein the actuator is operably coupled to a hingedassembly through a transmission assembly and configured to actuate thehinged assembly when the actuator is activated by the controller. 11.The wearable assistance system of claim 10, wherein the hinged assemblyincludes an insole bracket rotatably coupled with an upright member. 12.The wearable assistance system of claim 6, where the measurement deviceutilizes a measurement of oxygen consumption/CO2 production to determinea metabolic rate.
 13. A method of using an ankle exoskeleton device, themethod comprising: collecting one or more biomechanical data points froman individual; developing individualized musculoskeletal simulationsbased on the one or more biomechanical data points; utilizingestablished biomechanical relationships governing an interaction betweenthe device and the individual to create predictive simulations bymodeling effects of the ankle exoskeleton device on the individualmusculoskeletal simulations; determining gait deficits by comparing theresults of the individualized musculoskeletal simulations to data pointscollected on other individuals using the exoskeleton device; andmodifying a control system of the exoskeleton device based on thepredictive simulations and the gait deficits.
 14. The method of using anankle exoskeleton device of claim 13, wherein the collecting one or morebiomechanical data points from an individual includes utilizing motioncapture of movement and force gait analysis via motion capture camerasor utilizing on-board device sensors.
 15. The method of using an ankleexoskeleton device of claim 13, wherein the collecting one or morebiomechanical data points from an individual includes utilizing ameasurement of muscle activity through electromyography.
 16. The methodof using an ankle exoskeleton device of claim 13, wherein the collectingone or more biomechanical data points from an individual includesutilizing a measurement of oxygen consumption/CO2 production todetermine a metabolic rate.